External Device for an Implantable Medical System Having Accessible Contraindication Information

ABSTRACT

Disclosed is a remote controller for an implantable medical device having stored contraindication information, which includes information which a patient or clinician might wish to review when assessing the compatibility of a given therapeutic or diagnostic technique or activity with the patient&#39;s implant. The stored contraindication information is available through a display of the remote controller or via a wired, wireless, or portable drive connection with an external device. By storing contraindication information with the implant&#39;s remote controller, patient and clinician can more easily determine the safety of a particular therapeutic or diagnostic technique or physical activity with the patient&#39;s implant, perhaps without the need to contact the manufacturer&#39;s service representative.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation application of U.S. patent application Ser. No.14/461,426, filed Aug. 17, 2014 (pending), which is a continuation ofU.S. patent application Ser. No. 14/061,326, filed Oct. 23, 2013 (nowU.S. Pat. No. 8,812,129), which is a continuation application of U.S.patent application Ser. No. 12/498,061, filed Jul. 6, 2009 (now U.S.Pat. No. 8,588,925), which are all incorporated by reference, and towhich priority are claimed.

TECHNICAL FIELD

The present invention relates to the field of implantable medicaldevices, and in particular, to external devices that contain informationrelated to the patient and the implantable medical device system.

BACKGROUND ART

Implantable stimulation devices are devices that generate and deliverelectrical stimuli to body nerves and tissues for the therapy of variousbiological disorders, such as pacemakers to treat cardiac arrhythmia,defibrillators to treat cardiac fibrillation, cochlear stimulators totreat deafness, retinal stimulators to treat blindness, musclestimulators to produce coordinated limb movement, spinal cordstimulators to treat chronic pain, cortical and deep brain stimulatorsto treat motor and psychological disorders, and other neural stimulatorsto treat urinary incontinence, sleep apnea, shoulder sublaxation, etc.The present invention may find applicability in all such applications,although the description that follows will generally focus on the use ofthe invention within a Spinal Cord Stimulation (SCS) system, such asthat disclosed in U.S. Pat. No. 6,516,227.

Spinal cord stimulation is a well-accepted clinical method for reducingpain in certain populations of patients. As shown in FIG. 1, a SCSsystem typically includes an Implantable Pulse Generator (IPG) 100,which includes a biocompatible case 30 formed of titanium, for example.The case 30 typically holds the circuitry and power source or batterynecessary for the IPG 100 to function, although IPGs can also be poweredvia external RF energy and without a battery. The IPG 100 is coupled toelectrodes 106 via one or more electrode leads (two such leads 102 and104 are shown), such that the electrodes 106 form an electrode array110. The electrodes 106 are carried on a flexible body 108, which alsohouses the individual signal wires 112 and 114 coupled to eachelectrode. In the illustrated embodiment, there are eight electrodes onlead 102, labeled E1-E8, and eight electrodes on lead 104, labeledE9-E16, although the number of leads and electrodes is applicationspecific and therefore can vary.

FIG. 2 shows portions of an IPG system in cross section, including theIPG 100 and a remote controller 12. The IPG 100 typically includes anelectronic substrate assembly 14 including a printed circuit board (PCB)16, along with various electronic components 20, such asmicroprocessors, integrated circuits, and capacitors mounted to the PCB16. Two coils are generally present in the IPG 100: a telemetry coil 13used to transmit/receive data to/from the remote controller 12, and acharging coil 18 for charging or recharging the IPG's power source orbattery 26 using an external charger (not shown). The telemetry coil 13can be mounted within the header connector 36 as shown.

A remote controller 12 is used to communicate with and control apatient's IPG 100. Such external control is beneficial, because apatient's stimulation needs may change throughout the day. For example,different therapy settings may be required for when the patient issleeping, standing, sitting, or driving. Some settings are saved as“presets” or “programs” and can be selected by the patient using theremote controller 12. As well as being useable to select a particulartherapy program, the remote controller 12 can be used to increase ordecrease stimulation strength, select different areas of the body orelectrodes to be stimulated, and to shut off and turn on stimulation. Inaddition, the remote controller 12 can act as a receiver of data fromthe IPG 100, receiving various data reporting on the IPG 100's status.Remote controller 12 is hand-held and portable.

The communication of data from the remote controller 12 to the IPG 100occurs via magnetic inductive coupling. When data is to be sent from theremote controller 12 to the IPG 100, coil 17 is energized with analternating current (AC). Such energizing of the coil 17 to transferdata can occur using a Frequency Shift Keying (FSK) protocol forexample, such as disclosed in U.S. Patent Publication 2009/0024179(pending). Energizing the coil 17 induces an electromagnetic field,which in turn induces a current in the IPG's telemetry coil 13, whichcurrent can then be demodulated to recover the original data.

As is well known, inductive transmission of data or power occurstranscutaneously, i.e., through the patient's tissue 25, making itparticular useful in a medical implantable device system.

Clinicians treating patients with implantable medical devices that theyhave not implanted or are not familiar with may have doubts about theuse of various therapeutic or diagnostic techniques on such patients.For example, the clinician or the patient may have concerns related tothe compatibility of certain therapeutic or diagnostic techniques withthe patient's implant, such as use of computerized tomography (CT)scans, magnetic resonance imaging (MRI), diathermy, transcutaneouselectrical nerve stimulation (TENS), etc. Patients may also be worriedabout the compatibility with other non-medical related activities, suchas running, swimming, contact sports, taking an airplane, going throughX-ray checkpoints, etc., and to what extent such activities arecontraindicated by the patient's implant.

Usually such concerns take time to be addressed since the patient orclinician may need to contact the manufacturer of the implant system orits service representative regarding the proposed therapeutic ordiagnostic technique or desired activity and relevant contraindicationsarising from the implanted medical device. While patient manuals orclinician manuals provided with the implant system may contain thedesired information, patients and clinicians rarely have the informationavailable when needed.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a block diagram illustrating conventional implantable medicaldevices according to the prior art;

FIG. 2 is a block diagram illustrating the use of a remote controller tocommunicate with an implantable medical device according to the priorart;

FIGS. 3A-3C are top, bottom, and side views of a remote controller foran implantable medical device according to one embodiment for storingcontraindication information;

FIG. 4 is a block diagram illustrating an embodiment of circuitryelements for the remote controller of FIGS. 3A-3C; and

FIG. 5 is a user interface of the remote controller showing differentways of accessing the contraindication information.

FIG. 6 is a block diagram illustrating a variety of communication pathsfor connecting the remote controller of FIGS. 3A-3C to an externaldevice.

DESCRIPTION OF EMBODIMENTS

Implant system manufacturers regularly receive phone calls regardingimplant patients that need to undergo certain therapeutic or diagnosticmedical procedures, or that wish to partake in some sort of activitysuch as contact sports. While in many cases the information desired bythe patient or clinician is present in the manuals provided with theimplant system, patients and clinicians may still call themanufacturer's technical support representative to inquire about theimplantable medical device because the manual is not available to themat the time the information is needed. Even if the patient has themanuals, the patient or clinician may still have doubts regarding thecompatibility of certain therapeutic or diagnostic procedures or ofvarious other activities with the patient's implant, which doubts mayarise because of some particular medical condition or sensitivity of thepatient that is not addressed by the manuals.

To alleviate this problem, the embodiments disclosed below providecontraindication information in an improved remote controller 200associated with the patient's implantable medical device. Such“contraindication information” includes one or more of the followingpieces of information which a patient or clinician might wish to reviewwhen assessing the compatibility of a given therapeutic or diagnostictechnique or other activity with the patient's implant: the patient orclinician's manuals for the implant system, including the manuals forthe implant and any associated external devices (e.g., remotecontrollers or external chargers); any specific contraindicatedtherapeutic or diagnostic techniques or activities; contact informationfor the manufacturer of the implant system or its servicerepresentative; clinician contact information, for example the contactinformation of the clinician who implanted the implant, or anotherclinician having information relevant to the use of particulartherapeutic or diagnostic techniques or other contraindicated orcompatible activities; clinician instructions regarding therapeutic ordiagnostic techniques or activities compatible with or contraindicatedby the patient's implant; patient history or patient records relevant toa particular therapeutic or diagnostic techniques or activitiescompatible with or contraindicated by the patient's implant; etc. Asreferred to herein, “contraindication indication” also indicatesprocedures or activities that are compatible with the patient's implantas well as those that are prohibited, at least to some conditionaldegree.

Such contraindication information can be stored with the remotecontroller 200 at the time of the implant system's manufacture (e.g.,manufacture contact information; manuals), while other information canbe stored later (e.g., clinician contact information; patient history).The contraindication information can be conveyed to the patient orclinician directly via the remote controller's user interface, e.g., thedisplay associated with the remote controller. Alternatively, the storedcontraindication information may be conveyed to the clinician or patientvia a connection with a computer, a personal digital assistant (PDA), orsimilar device. The connection may be wired, e.g., a Universal SerialBus (USB), serial port, or parallel port connection; wireless, e.g.,BLUETOOTH®, WI-FI®, or infrared connections; or can comprise a portableremovable storage device such as a memory card or a USB thumb drive.Hardware and communication links for storing and retrievingcontraindication information in and from the remote controller arediscussed in further detail herein.

Clinicians or patients able to access the contraindication informationstored with the remote controller 200 can take proactive measuresagainst contraindicated procedures and activities, therefore improvingpatient safety. Clinician, patient, and the implant system manufacturercan also download additional contraindication information to the remotecontroller later to improve even further the accuracy and usefulness ofthe information going forward. Because the remote controller is usedoften by the patient and is easily accessible to the patient orclinician, providing contraindication information with the remotecontroller eases confusion and uncertainty when the patient requires aparticular contraindicated procedure. Convenient access tocontraindication information is further facilitated due to the hand-heldor portable nature of the remote controller.

The description that follows relates to use of the invention within aspinal cord stimulation (SCS) system. However, the present invention isnot so limited. Rather, the present invention can be used with any typeof implantable medical device system that could benefit from an enhancedremote controller. For example, the present invention can be used aspart of a system employing an implantable sensor, an implantable pump, apacemaker, a defibrillator, a cochlear stimulator, a retinal stimulator,or in any other neural stimulator configured to treat any of a varietyof conditions.

Disclosed are various embodiments by which relevant contraindicationinformation can be associated with the patient's remote controller 200.As shown in one example in FIG. 3A, the improved remote controller 200provides contraindication information on a removable storage 300. Toaccommodate removable storage 300, the remote controller 200 includes aremovable storage interface 319 into which the removable storage 300 canbe inserted or to which the removable storage 300 can otherwise becoupled. Removable storage 300 are typically small thin cards containingmemory intended for removable data storage, and typically comprise flashEEPROM memory. At present, common forms of removable storage 300comprise Secure Digital (SD®), Mini SD, MICRO SD®, SD HC®, or MEMORYSTICK® memory cards, etc. Some removable storage interfaces 319 can beused with a variety of different removable storage 300. Removablestorage 300 are available in a variety of memory capacities fromnumerous sources. A typical removable storage 300 may have at least 1 GBof storage capacity, although smaller or larger capacity removablestorage 300 can be used in conjunction with remote controller 200 asdesired. Removable storage 300 may contain a write-protection notch orswitch on its body to inform the removable storage interface 319 whetherthe removable storage 300 may be only read or whether it canadditionally be written to, although such protective measures are notstrictly necessary.

Turning to FIGS. 3B and 3C, bottom and side views of the remotecontroller 200 with its housing removed illustrate the removable storageinterface 319 in relation to other elements of the remote controller200. The removable storage interface 319 is preferably a read/writeunit, allowing the remote controller 200 to read data previously storedon a removable storage 300, as well as write data to the removablestorage 300. The position and orientation of the removable storageinterface 319 are illustrative and by way of example only, and it can bepositioned and oriented in any location or orientation that isconvenient or desired. A slot in the housing of the remote controller200 corresponding to a slot in the removable storage interface 319allows insertion or extraction of the removable storage 300 into or outof the removable storage interface 319. In some embodiments, theremovable storage interface 319 includes a protective cover over theslot (not shown). Although only a single removable storage interface 319is shown, multiple interfaces can be included if desired.

In addition to the removable storage interface 319, the remotecontroller 200 typically include a user interface 390 (FIG. 3A), whichgenerally includes a display screen 365, which can be a liquid crystaldisplay (LCD) screen or any other display technology. Various buttons370-376 on the user interface 390 can be used by the patient to operatethe functions available with the remote controller 200. The arrangement,number, and positioning of buttons 370-376 are illustrative and by wayof example only, and other indicator lights, buttons, or userinteraction elements, including a numeric keypad or alphanumerickeyboard, can be provided by the remote controller 200 as desired. Theuser interface 390 may also include a speaker (not shown). As will bediscussed further within, contraindication information can be accessedby a patient or clinician via the remote controller's user interface390.

As best shown in FIG. 3B, the remote controller 200 can also include anon-removable storage 321 for providing data storage, whichnon-removable storage 321 can also include the contraindicationinformation discussed earlier. Non-removable storage 321 is preferablynon-volatile such as a flash EEPROM memory, but may also comprise avolatile memory such as an SRAM or DRAM memory. Non-removable storage321 can also comprise other non-solid-state forms of storage as well,such as a hard disk, for example. Non-removable storage 321 can be inaddition to, or as an alternative to, the removable storage 300described above. The remote controller 200 can include multiple kinds ofnon-removable storage 321, some of which can be read-only memory, andsome of which can be read-write memory. Operating software for theremote controller 200 is typically stored on the non-removable storage321, including controlling communications with the IPG 100, driving thedisplay 365, and reading data from and writing data to the removablestorage 300 when coupled with the removable storage interface 319.

The remote controller 200 can also include a port 315 for wiredcommunication with an external device, which port 315, like removablestorage interface 319, can also be used as a means for receiving ortransmitting contraindication information to or from the remotecontroller 200. Port 315 can in one example comprise a Universal SerialBus (USB) port, although other types of ports can be used as desired forwired connectivity, including other types of serial ports, parallelports, Ethernet ports, etc. The operating software for the remotecontroller 200 controls the port 315, including reading and writing databetween the removable storage 300 and the port 315.

In addition to using the USB port 315 for wired communication, the USBport 315 can interface with a portable external removable storage devicesuch as a USB thumb drive 510, as will be discussed further with respectto FIG. 6.

Where a removable storage 300 is used in conjunction with remotecontroller 200, the removable storage 300 can be loaded with therapeuticand diagnostic information externally to the remote controller 200 andthen inserted into the removable storage interface 319 for use by theremote controller 200. For example, the manufacturer of the medicalimplant system can store the implant system manual(s) orcontraindications on the removable storage 300 for use by the patient orclinician, who can in turn review the manual on the remote controller'sdisplay 365, or on another external computer as will be discussed infurther detail later. Additionally, using a removable storage 300 tostore contraindication information makes it easier for the manufacturerof the system to provide updated information to the patient. Forexample, if the manufacturer updates the manuals, perhaps by providingnew contraindications or compatibilities, their implant customers cansimply be sent a new removable storage 300 card in the mail, withoutrequiring the remote controller 12 to network with other devices. Forexample, such a new card might contain the following newcontraindication information: “Although the manufacturer previouslyrecommended that patients not swim with their implant, or pass throughX-ray machines, subsequent testing has shown these previously prohibitedactivities to be safe.” Although new removable storage cards can beconvenient, networking can also be very advantageous and convenient wayof providing contraindication information to and from the remotecontroller 200, and comprises other embodiments discussed below.

Contraindication information can also be written to the removablestorage 300 by the remote controller 200. In this scenario, theinformation (e.g., the manuals) can be resident in the remote controller200 (e.g., in memory 321), or can be input (e.g., by a clinician) intothe remote controller 200 via its user interface 390, or can beotherwise be communicated to the remote controller 200 from an externaldevice such as a computer (e.g., particular clinician instructions orpatient history regarding therapeutic or diagnostic techniquescompatible or contraindicated by the patient's implant). In any event,once the contraindication information is stored on the removable storage300 in this fashion, the removable storage 300 may then be removed fromthe remote controller 200 and taken to another computer platform (forexample, a clinician's computer) to review that information, asexplained further in connection with FIG. 6.

The non-removable storage 321 is similar to the removable storage 300,except of course as concerns its portability to other platforms. Thus,contraindication information can be written to the non-removable storage321 by the remote controller 200 at manufacture or later times as justdiscussed, or the information can be read from the non-removable storage321 for display at the remote controller 200 or for transmission toanother platform.

Any convenient file format can be used for storing the contraindicationinformation in the remote controller 200, including plain text files,structured files such as eXtended Markup Language (XML) files, PortableData Format (PDF) files, or any other file format. The remote controller200 in some embodiments is capable of displaying some or all of thestored information on the display 365, but the information stored by theremote controller 200 is not limited to information that is directlydisplayable by the display 365. For example, a PDF file of clinicianinformation can be stored on the remote controller 200 even inembodiments that do not include software to display PDF files on thedisplay 365. In such embodiments, the non-displayable information can becommunicated to, accessed, and displayed by an external device such asthe computer 500 illustrated in FIG. 6.

Additionally, the contraindication information stored with the remotecontroller 200 can include hypertext links to additional information,which can be accessed from the Internet (520; FIG. 6) by a web browserexecuted by an external computer used by the clinician. In someembodiments, the remote controller 200 can include web browser andnetwork connectivity software allowing such links to be accessed whiledisplaying the resulting information on the display 365.

Further shown in FIG. 3B is a wireless transceiver 480 that, like ports315 and 319, can be used to receive or transmit contraindicationinformation to or from the remote controller 200. Wireless transceiver480 preferably enables a radio frequency (RF) link, such as a BLUETOOTH®or WI-FI® compliant link, but can also enable an optical link, such asan infrared link conforming to the specifications defined by theInfrared Data Association (IrDA). Additionally, communication coil 17,traditionally used as the antenna for communications with the IPG 100,can also be used as a communication link for carrying contraindicationinformation to or from the remote controller 200, as discussed furtherin FIG. 6.

FIG. 4 is a block diagram illustrating an embodiment of circuitry 400for storing and communicating therapeutic and diagnostic information inthe remote controller 200. A microprocessor 470 provides processinglogic for the various features and functions of the remote controller200, and as particularly relevant here, provides processing logic forreading, writing, and controlling the communication of thecontraindication information, as well as for controlling the IPG 100,typically under the control of the operating software stored on thenon-removable storage 321. Power to the remote controller 200 isprovided by the battery 326.

The antenna coil 17 allows for communication with the IPG 100, such asfor communicating therapy settings wirelessly to the IPG 100, or withother external systems as will be explained further below. The coil 17can both transmit and receive information via transmitter 410 andreceiver 420 respectively. Because the transmitter 410, receiver 420,and other associated illustrated components are well known in the art,they are not further discussed.

A crystal 440 provides clocking for the microprocessor 470. The displayscreen 365 provides the ability to display information to a user of theremote controller 200, including the contraindication informationdiscussed herein. User interaction typically occurs through a key pad455, which provides an interface to the buttons 370-376 discussedearlier. Also illustrated are USB port 315 and wireless transceiver 480discussed previously, which are controlled by the operating software ofthe remote controller 200. Removable storage interface 319 andnon-removable storage 321 discussed earlier are also illustrated asassociated with the microprocessor 470.

FIG. 5 shows the user interface 390 on the remote controller 200 used toaccess the contraindication information. As shown, the contraindicationinformation appears in a menu 230 on the remote controller's display365, under which are listed several selectable types 232 ofcontraindication information mentioned previously, such as the manuals,contraindications, manufacturer contact information, etc. Menu 230 isdesignated as a “read” menu, meaning that the listed information typescan only be read from this menu. However, a corresponding “write” menu(not shown) could allow these same information types to be written. Theclinician or patient can select to review any of these types ofinformation using the user interface's buttons as discussed earlier. Forexample, selection of “Contraindications” might reveal the following:“Because implant is near the patient's pelvis, MRI can only be used onthe head and below the knees. No MRI should be taken of the patient'smidsection. TENS should not be performed without first turning off thepatient's implant using the remote controller.” Selection of “Manual”may reveal this same information, although perhaps not as succinctly.Contraindication information stored with the remote controller 200 canalso be conveyed to the patient or clinician using other aspects of theuser interface 390, such by broadcasting the information in spoken formfrom a speaker for example.

The user interface 390 of the remote controller 200 may also be used toenter contraindication information. This might involve accessing thecorresponding “write” menu discussed above, or otherwise manipulatingthe user interface 390 to allow the entry of contraindicationinformation. For example, a clinician upon selecting (in the “write”menu) the option “Clinician Instruction” might input the following forthe benefit of future clinicians: “The patient's implant is located inthe upper right buttocks and contains a lead tunneled into the spinalcord. Please take precautions when performing surgery in this area. Formore information, contact Dr. Lewis at [phone number].” Entering suchinformation may require a user interface 390 having alphanumeric inputcapability, which means are well known. Once input, this newcontraindication information is appropriately stored, e.g., in theremovable storage 300 or non-removable storage 321, and then would beaccessible via the corresponding entry in the “read” menu. Of course,having separate “read” and “write” menus for contraindicationinformation is not required, and any other means of file management forreading and writing the information using the user interface can beused.

FIG. 6 shows various communication paths by which the contraindicationinformation in the remote controller 200 can be remotely accessed by thepatient or clinician. Such communication paths are especially usefulwhen another external device is used to access the contraindicationinformation, e.g., if the remote controller's user interface 390 (FIG.3A) is not used for accessing the stored contraindication information ata given moment. Such communication paths are also useful whencontraindication information is being written to the remote controller200, for example, during manufacturing, upon implantation, orafterwards.

As shown, the remote controller 200 communicates with a computer 500.Computer 500 can comprise any generic computing device, and can differdepending on its context. For example, computer 500 can comprise amanufacturer's computer that is used during manufacture to writecontraindication information (e.g., manufacturer contact information;manuals) into the memory (e.g., 321 or 300) associated with the remotecontroller 200. Computer 500 may also comprise a clinician's computerthat is used to review contraindication information (again, e.g.,manufacturer contact information; manuals) stored in the remotecontroller 200 (e.g., memories 300 or 321), or that is used to writenew, additional, or updated contraindication information (e.g., e.g.,clinician contact information; patient history) into the remotecontroller 200. Computer 500 can also comprise the patient's homecomputer.

Computer 500 can comprise any device capable of performing the disclosedcommunication techniques, including general purpose computers, specialpurpose clinical or manufacturing devices, portable computing devicessuch as PDAs or notebook computers, etc. Regardless, computer 500 canhave connectivity to any suitable network 520, such as the Internet,which provides additional communication flexibility to the implantsystem as one skilled in the art will understand. For example, shouldthe implant system manufacturer update the implant system manual(s)after its initial release, perhaps with new information regardingcontraindications, this updated information may be downloaded from theInternet 520 to the remote controller 200 (e.g., memories 300 or 321)via computer 500 at future times.

As shown in FIG. 6, if the contraindication information is stored on aremovable storage 300 associated with the remote controller 200, theclinician or patient can remove the removable storage 300 and insert itinto a removable storage interface 507 on computer 500, which interface507 can be similar to the removable storage interface 319 on the remotecontroller 200 discussed earlier. If the contraindication information isstored either in removable storage 300 or in non-removable storage 321,then that information could alternatively be sent to the computer 500via a cable 511 coupled between port 315 on the remote controller 200and port 505 on the computer 500. Such ports 315 and 505 can compriseUSB ports, but as noted earlier, this is not strictly necessary. Oncereceived at the computer 500, the contraindication information can beeasily reviewed using the computer's user interface.

Contraindication information could also be wirelessly sent from eitherof memories 300 or 321 to the computer 500 via wireless link 514 usingwireless transceivers 480 and 509 in the remote controller 200 and thecomputer 500 respectively. Contraindication information stored inmemories 300 or 321 can also be transferred to computer 500 using a USBthumb drive 510. As is well known, and similar to removable storage 300,USB thumb drive 510 typically comprises non-volatile solid-state memory,although USB thumb drive 510 can also comprise a hard drive-basedportable memory. Regardless, contraindication information can betransferred from the remote controller 200 to USB thumb drive 510 viaport 315, after which the USB thumb drive 510 can be placed in port 505on the computer 500 for review by the manufacturer, patient, orclinician.

In another embodiment shown in FIG. 6, contraindication informationstored in memories 300 or 321 can be conveyed to the computer 500 usingan intermediary coil 530 as shown in FIG. 6. Intermediary coil 530 cancomprise a coil, which like coil 13 in the IPG 100 (see FIG. 2), cancommunicate with coil 17 in the remote controller 200 using magneticcoupling and a suitable modulation scheme such as FSK for example.Intermediary coil 530 can be hard-wired to computer 500, or can belinked to computer 500 through wireless means. Regardless, intermediarycoil 530 allows contraindication information to be uploaded from theremote controller 200 to the computer 500, or vice versa, via magneticinduction by conveniently using the same communication coil 17 used tocommunicate with the IPG 100. If an intermediary coil 530 is used, othermore specialized communication links (USB port 315; wireless transceiver480) may not be necessary.

Once the contraindication information has been transferred to thecomputer 500, it can be conveyed to the user using the computer's userinterface, e.g., the computer's display or speakers. Such computerinterface can essentially mimic the functionality of the user interface390 of the remote controller 200 illustrated earlier in FIG. 5, and thusis not redundantly illustrated. However, the added processing complexityof the computer 500 might allow for even more sophisticated manners ofcontraindication information review.

As mentioned earlier, an external device such as computer 500 can alsobe used to write contraindication information into the remote controller200, i.e., to memory 300 or 321. This is advantageous for example whenthe manufacturer wants to program the manuals or contact informationinto the remote controller 200. If computer 500 comprises a clinician'scomputer, the clinician can use computer 500 to write patient-specificor non-patient-specific implant compatibilities or contraindicationsinto the remote controller 200, which written information can then bereviewed by subsequent clinicians treating the implant patient (e.g.,using menu 230; FIG. 6). For example, suppose the implant patient had anegative reaction to an MRI, such as uncomfortable heating of theimplant. The clinician could use her computer 500 to download thefollowing note to either of memories 300 or 321 in the remote controller200: “Patient experienced discomfort relating to heating during MRIprocedure of the pelvis. Use caution when MRI-ing this area. Recommendusing powers lower than X when performing an MRI, especially on pelvisarea.”

Such writing of contraindication information from the computer 500 intothe remote controller 200 (e.g., memories 300 or 321) can occur throughthe same bi-directional communication links discussed previously. Forexample, contraindication information can be written from the computer500 to the remote controller 200 via card slot 507 to the removablestorage 300; via USB port 505 using a wired connection 511 or a USBthumb drive 510; via wireless transceiver 509; via intermediate coil530, etc. Once programmed into the remote controller 200, thecontraindication information can be conveyed to the patient or clinicianusing the user interface 390 of the remote controller 200, or cansubsequently be conveyed to the patient, clinician or other interestedparty via the computer 500.

Because the contraindication information stored in the remote controller200 may comprise Protected Health Information (PHI), as that term isdefined by the Health Insurance Portability and Accountability Act of2003 (HIPAA), the remote controller 200 may be required to useencryption to protect the PHI. Various encryption techniques can beused, depending on the embodiment and the encryption techniques used byany external devices or systems with which the remote controller 200communicates. Where the PHI is stored on a removable storage 300, thenthe PHI is typically encrypted as stored on the removable storage 300.

Because some contraindication information may not be suitable forpatients, some embodiments of the remote controller 200 software canprovide for password or other access controls over such informationstored by the remote controller 200. The access controls can be embeddedinto the stored information itself or separately maintained in the filesystem on the storage device, whether removable or non-removable. Insome embodiments, the remote controller 200 software can provide foraccessing access-controlled information on the remote controller 200,such as by entering a password using one or more of the keys 370-374 orother such user interaction elements. In other embodiments, theaccess-controlled information cannot be opened on the remote controller200, but can be accessed by an external device such as computer 500,using software on the external device to open the access-controlledinformation.

Embodiments of the improved remote controller 200 and the system inwhich it communicates were conceived in the context of providing easieraccess to contraindication information regarding implant patientsneeding to undergo a particular contraindication process. However, itshould be noted that an improved remote controller 200 and system arenot so limited, and that many different types of information could bestored at or communicated to or from the remote controller. Disclosedembodiments of the external device and its system should therefore notbe limited to contraindication information unless so limited by theattached claims.

Moreover, the invention can be embodied in other external devicesassociated with a patient's implant. For example, a hand-held orportable external charger used to wirelessly recharge the battery in apatient's IPG 100 can also contain the contraindication information, andcan function or be made to function as disclosed herein. An example ofan external charger is disclosed in U.S. Patent Application Publication2008/0027500 (pending).

Although particular embodiments of the present invention have been shownand described, it should be understood that the above discussion is notintended to limit the present invention to these embodiments. It will beobvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present invention. Thus, the present invention is intended to coveralternatives, modifications, and equivalents that may fall within thespirit and scope of the present invention as defined by the claims.

What is claimed is:
 1. An external device for use with a medical device,comprising: a housing configured to be portable and hand-holdable; astorage within the housing, wherein the storage stores informationrelevant to compatibility of an activity or procedure with the medicaldevice; communication circuitry within the housing; and a user interfaceon the housing, wherein the user interface comprises a display, whereinthe user interface is configured to allow a user of the user interfaceto wirelessly communicate directly with the medical device via thecommunication circuitry, and convey the information from the storage tothe display for review by the user.
 2. The external device of claim 1,wherein the user interface is configured to allow the user to wirelesslycommunicate one or more of: therapy settings for the medical device; atherapy program for the medical device; data to increase or decreasestimulation strength of the medical device; and data to shut off andturn on stimulation.
 3. The external device of claim 1, wherein theexternal device further comprises a removable storage interface or aport, and wherein the storage comprises a removable storage coupleableto the removable storage interface or the port.
 4. The external deviceof claim 1, wherein the storage is non-removable from the externaldevice.
 5. The external device of claim 1, wherein the external deviceis configured to receive new, additional, or updated information, and tostore the new, additional, or updated information in the storage.
 6. Theexternal device of claim 1, wherein the procedure comprises a medicaltherapeutic or diagnostic technique.
 7. The external device of claim 1,wherein the activity comprises a physical activity performable by apatient of the medical device.
 8. The external device of claim 1,wherein the activity or procedure comprises an activity or procedurecompatible with or contraindicated by the medical device.
 9. Theexternal device of claim 1, wherein the information comprises clinicianinstructions relevant to compatibility of an activity with the medicaldevice.
 10. The external device of claim 1, wherein the informationcomprises information specific to a patient of the medical device. 11.The external device of claim 1, wherein the information furthercomprises one or more of patient or clinician's manuals for the externaldevice or the medical device, medical device manufacturer or servicerepresentative contact information, or clinician contact information.12. The external device of claim 1, wherein the communication circuitrycomprises a coil, and wherein the user interface is configured to allowthe user of the user interface to wirelessly communicate directly withthe medical device by producing at the coil a field receivable at themedical device.
 13. The external device of claim 1, wherein thecommunication circuitry is further configured to wirelessly transmit theinformation from the external device.
 14. An external device for usewith a medical device, comprising: a housing configured to be portableand hand-holdable; a storage within the housing, wherein the storagestores information, wherein the information comprises one or more ofpatient or clinician's manuals for the external device or the medicaldevice, medical device manufacturer or service representative contactinformation, or clinician contact information; communication circuitrywithin the housing; and a user interface on the housing, wherein theuser interface comprises a display, wherein the user interface isconfigured to allow a user of the user interface to wirelesslycommunicate directly with the medical device via the communicationcircuitry, and convey the information from the storage to the displayfor review by the user.
 15. The external device of claim 14, wherein theuser interface is configured to allow the user to wirelessly communicateone or more of: therapy settings for the medical device; a therapyprogram for the medical device; data to increase or decrease stimulationstrength of the medical device; and data to shut off and turn onstimulation.
 16. The external device of claim 14, wherein the externaldevice further comprises a removable storage interface or a port, andwherein the storage comprises a removable storage coupleable to theremovable storage interface or the port.
 17. The external device ofclaim 14, wherein the storage is non-removable from the external device.18. The external device of claim 14, wherein the external device isconfigured to receive new, additional, or updated information, and tostore the new, additional, or updated information in the storage. 19.The external device of claim 14, wherein the information furthercomprises at least one activity or procedure compatible with orcontraindicated by the medical device, wherein the procedure comprises amedical therapeutic or diagnostic technique, and wherein the activitycomprises a physical activity performable by a patient of the medicaldevice.
 20. The external device of claim 14, wherein the informationfurther comprises information specific to a patient of the medicaldevice.
 21. The external device of claim 14, wherein the communicationcircuitry comprises a coil, and wherein the user interface is configuredto allow the user of the user interface to wirelessly communicatedirectly with the medical device by producing at the coil a fieldreceivable at the medical device.
 22. The external device of claim 14,wherein the communication circuitry is further configured to wirelesslytransmit the information from the external device.